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25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo

Proellex

placebo

Andre vanAs, MD, PhD

Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

A Phase III, Three-Arm, Parallel Design, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

Repros Therapeutics Inc.

25 mg oral daily dose of Proellex

Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo

25 g Proellex

50 mg oral daily dose of Proellex

Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo

50 mg Proellex

Placebo

Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo

Total

Age, Continuous

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Female

Male

Sex: Female, Male

United States

Region of Enrollment

The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

Jennifer Wike

To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)

Proellex: 25 mg or 50 mg or placebo oral daily dose

All Arms

Overall Study

One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months

Two 25 mg mg capsules of Proellex® orally daily for up to four months

Two placebo capsules orally daily for up to four months

Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

A Phase III, Three-arm, Parallel Design, Placebo-controlled, Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

25 mg oral daily dose of Proellex

Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months

25 mg Proellex

50 mg oral daily dose of Proellex

Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months

oral daily dose of placebo

Placebo: Two placebo capsules orally daily for up to four months

25 mg, 50 mg oral daily dose of Proellex or placebo

All Groups

Andre vanAS, PhD, Md

Safety and efficacy study of 25 and 50 mg doses of Proellex

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids	NCT00853567	Uterine Fibroid...	Proellex placebo	18 Years - 48 Years	Repros Therapeutics Inc.
Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids	NCT00853567	Uterine Fibroid...	Proellex placebo	18 Years - 48 Years	Repros Therapeutics Inc.
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids	NCT00735553	Uterine Fibroid...	Proellex Proellex Placebo	18 Years - 48 Years	Repros Therapeutics Inc.
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids	NCT01069120	Uterine Fibroid...	Proellex Proellex	18 Years -	Repros Therapeutics Inc.
Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids	NCT00853567	Uterine Fibroid...	Proellex placebo	18 Years - 48 Years	Repros Therapeutics Inc.
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids	NCT01069120	Uterine Fibroid...	Proellex Proellex	18 Years -	Repros Therapeutics Inc.

Spots Global Cancer Trial Database for proellex

Every month we try and update this database with for proellex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for proellex

Every month we try and update this database with for proellex cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for proellex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.